• Provide expert guidance on pharmaceutical manufacturing and quality assurance processes.• Assist clients in the development, validation, and implementation of cGMP-compliant procedures and systems.• Conduct audits and assessments to ensure compliance with regulatory requirements and industry standards.• Develop and optimize processes for product development, scale-up, and technology transfer.• Collaborate with cross-functional teams to support the design and qualification of manufacturing facilities and equipment.• Offer strategic insights into supply chain management, supplier qualification, and risk assessment.• Deliver training and support for clients on quality management systems and best practices.

• Responsible for the oversight of Quality Assurance functions including QA Systems, Incoming QA, Compliance, QA Operations, and QA Inspections.• Administered and set annual budget for the quality assurance team. Responsible for the professional development and performance management of the team.• Responsible for the risk-based implementation of the Pharmaceutical Quality System (PQS) and Quality Management System software (Document Management, Training Program, Deviation, CAPA, Change Control, Supplier Quality, Audit Program, and Compliant Handling) according to ICH Q9 and Q10. • Provided oversight and accountability for the incoming materials management program. Responsible for release decisions and management of the material review board. Provided cross-functional support for the Enterprise Resource Planning software implementation. Approved specifications for product, excipients, API, components, and consumables.• Developed and approved procedures to support compliance and operations functions, including: internal audit, supplier qualification, handling health authority inspections, deviation management, and CAPA. • Provided on-the floor support during filling operations and real-time batch record review. Responsible for the final approval of product release. Implemented Batch Release program.• Managed supplier quality program by leading audits of critical suppliers and approving qualification reports. Responsible for setting the annual audit schedule and budget. • Provided oversight of the QA Inspections program. Approved visual detection threshold studies and qualification of inspectors.

• Responsible for the oversight of Quality Control functions including Microbiology, Analytical Chemistry, Method Transfer and Validation, and Analytical Instrument Qualification.• Administered and set annual budget for the quality control team. Responsible for the professional development and performance management of the team.• Provided oversight and accountability for the design and construction of the microbiology and analytical laboratories. Responsible for the procurement and qualification of analytical equipment and supporting assets. • Developed and approved quality control procedures including method transfer procedures, compendial verification, laboratory investigations for out of tolerance / specification, utility monitoring, and environmental monitoring programs. • Oversaw the implementation of laboratory information systems and software including MODA-EM, TULIP, and data acquisition software for analytical instruments. • Responsible for the contamination control strategy for the facility and performing the environmental performance qualification of the facility.• Responsible for the oversight of technical transfers of client methods.

• Authored commissioning and qualification plan for greenfield sterile parenteral manufacturing startup. Assisted in the development of the facility design to ensure critical area and laboratory requirements were met. • Responsible for procurement of laboratory equipment. Assisted in the procurement of production equipment (filler, isolator, tunnel, rinser, autoclave, parts washer). • Authored, reviewed, and approved quality unit policies, procedures, and protocols. • Approved qualification and audit reports for new suppliers. Led and performed supplier qualification audits for critical material suppliers. • Recruited and developed quality unit team.

• Conducts data and process analysis activities including in-depth analysis of deviation and operational performance data. Evaluates data for trends and opportunities for improvement. Facilitates and/or leads improvement initiatives including the use of Six Sigma, Lean, and other improvement tools and methodologies.• Supports the internal audit program. Assists operations in evaluating observations, performing investigations, and root cause analysis. Aids in the development of corrective action. Performs follow-up on audit observations. • Performs failure mode analysis, risk analysis, risk assessments, and flow analysis of process changes. Conducts analysis on pilot and validation study data. Analyzes process changes. Works with Central Office Performance Improvement and operational staff to evaluate performance improvement needs. • Ensures requests for required regulatory licenses are submitted timely.• Tracks and trends deviations. Identifies areas for improvement and communicates these issues to operations. Ensures all required deviation management reports are accurate and timely. Ensures data entry is performed and events are accurately coded in data management system. Reviews and approves corrective action. Performs effectiveness checks for corrective actions.• Facilitates recalls and market withdrawals.• Hosts external inspections. Assists in facilitating responses to observations. Ensures corrective actions were implemented and effective. • Performs review of documents to ensure processes are within control (e.g., QC data, validations, proficiency testing).• Participates on review team to evaluate nonconforming products, materials, or test results and assesses the impact on external customers. Ensures required actions are implemented.

• Conduct and/or train EM personnel on performing investigations.• Review lab results for accuracy and compliance with SOPs.• Serve as a backup for all lab personnel (water testing, particle monitoring, EM monitoring, HEPA testing, etc.)• Administer the EM Database: oversee the training of EM technicians on the use of the database and ensure database accuracy.• Review and/or prepare SOPs as needed for EM.• Establish objectives and conduct performance reviews with direct report personnel• Conduct investigations related to EM data excursions and provide the written assessments as needed for Action/Alert Investigations and Level 1/2/3 Incidents • Monitor EM regulatory agency changes, guidance documents and USP revisions and recommend necessary changes• Manage the data entry and issuance and disposition of all EM data forms• Notify management of possible problems with ISO-classified areas, WFI system, and other areas related to EM.

Ensure pharmaceutical products are within specifications and meet all regulatory requirements to guarantee safety.

Organize teams to compete in the First Lego League at a local elementary school. The teams design robots, create programs to execute missions, and research a topic to present during the competition. Teach introductory robotics and programming courses for grades K-6.

• Test for product purity in a variety of chemical compounds by flame atomic absorption, UV/Vis spectroscopy, chromatography, potentiometry, and coloumetry methods.• Develop methods for analyzing new products and write corresponding SOP's.• Trained in utilizing the Lean Method for process improvements.• Maintain instruments and troubleshoot problems to ensure optimal performance.

• Prepare charts and graphs, write simple Linux bash scripts, and computer modeling using GCMC method.

• Ensure mail is sorted and delivered in an accurate and timely manner.